Report shows how the FDA incorporates the two ISO standards in its medical device development policy, how the EU version of the two standards differs in significant ways and how the EU Medical Device Regulation may require further changes in the European standards.

FDA Approves AUVI-Q Epinephrine Auto-Injector for Infants and Small Children

The FDA approved Kaleo’s epinephrine auto-injector, AUVI-Q, at 0.1 mg doses designed for use in infants and small children between 7.5 and 15 kgs. The supplemental NDA was granted priority review by the FDA.

The new auto-injector has a shorter needle length and lower dose of epinephrine than current FDA-approved 0.15 mg and 0.3 mg epinephrine auto-injectors.

The company projects the AUVI-Q 0.1 mg will be available in the first half of 2018.